February 12, 2018

Precision BioLogic is pleased to announce the publication of data from a recent research study conducted in conjunction with Sobi, an international specialty healthcare company dedicated to rare diseases, to assess agreement between European haemostasis laboratories in measuring FIX activity in plasma samples containing various levels of rFIXFc (Alprolix®). Findings will help laboratories to be aware of their level of variability and address it to allow for proper patient treatment.

The study revealed a dose-dependent variability in overall FIX measurement and a variability between each reagent-analyser combination used. Most of the laboratories were able to recover rFIXFc activity within 30% of expected values by using their own calibrator and FIX clotting assay system. Results were consistent with previous field studies in other regions and were presented as a poster—Assessment of clotting activity of recombinant FIX Fc fusion protein in European haemophilia treatment centres—at the 11th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), which took place in Madrid, Spain, February 7–9, 2018. The poster was co-authored by individuals from Precision BioLogic, Sobi and Copenhagen University.

In addition to co-authoring the poster, Precision BioLogic manufactured and distributed the frozen sample sets, and managed the field study and data processing.

“Precision BioLogic’s involvement with this study reflects our ongoing commitment to the hemophilia community,” says Paul Empey, President & CEO of Precision BioLogic. “It exemplifies one of several important projects we have underway.”

Between 2014 and 2016, Precision BioLogic was active in similar studies in Canada, the US, Australia and New Zealand. The studies were funded by Biogen (now Bioverativ) and results were published as posters:

Recombinant Factor IX Fc Fusion Protein (rFIXFc) Clotting Activity Assessment in International Hemophilia Treatment Centers (THSNA 2016, Chicago, USA)

Assessment of clotting activity of recombinant factor IX Fc fusion protein (rFIXFc) in plasma samples at haemophilia treatment centres in Australia and New Zealand (HFA 2015, Gold Coast, Australia and HAA 2015, Adelaide, Australia)

Assessment of Recombinant Factor IX Fc Fusion Protein (rFIXFc) Clotting Activity in Plasma Samples at Canadian Hemophilia Treatment Centres (ISTH 2015, Toronto, Canada)

Visit Our Publications page to view posters available for downloading.

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